RecruitingNot ApplicableNCT02966886

TSA Techniques in Glenohumeral OA

Comparison of Shoulder Arthroplasty Techniques in the Treatment of Glenohumeral Osteoarthritis: Protocol


Sponsor

Ottawa Hospital Research Institute

Enrollment

216 participants

Start Date

Apr 23, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

Osteoarthritis (OA) of the shoulder is a disease resulting from the wearing down of cartilage over time. OA can produce pain and dysfunction at the affected joint and is a growing occurrence in an aging population. Total shoulder arthroplasty (TSA) is a surgical treatment used to treat patients with shoulder OA which involves replacing the worn-out ball and socket shoulder joint with prosthetic components. TSA is performed today with high success rates, however, complication rates associated with TSA remain prevalent particularly when the arthritis is associated with bone erosion on the glenoid (socket). Given the high rate of revisions associated with TSA treatment in the setting of glenoid bone erosion, a number of surgical strategies have been developed. These surgical techniques include eccentric reaming which involves removing bone from the front of the socket, augmented glenoid component implantation, and posterior bone grafting to compensate for glenoid bone loss, and reverse shoulder arthroplasty. Few research studies have compared these different surgical techniques to one another. Previous studies have been limited to case series with small sample sizes and respective designs. This study is being conducted to determine which approach produces better outcomes. For the purpose of this study we will be comparing total shoulder arthroplasty techniques a) augmented glenoid component and eccentric reaming and b) augmented glenoid component and bone grafting in participants with advanced glenohumeral osteoarthritis.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares different surgical techniques for shoulder replacement in people with advanced glenohumeral (shoulder joint) osteoarthritis. It focuses on patients whose shoulder socket (glenoid) has an abnormal angle (retroversion), which makes standard replacement surgery more challenging. You may be eligible if: - You have advanced shoulder osteoarthritis that has not improved after at least 6 months of non-surgical treatment (medications, physiotherapy, activity changes) - Your shoulder socket has a retroversion angle between 10 and 26 degrees - Imaging confirms significant cartilage loss in your shoulder joint - You are 18 years of age or older You may NOT be eligible if: - Your glenoid retroversion is less than 10 or more than 26 degrees - You have an active joint or systemic infection - You have rotator cuff arthropathy, significant muscle paralysis, or Charcot's arthropathy - You have a major illness limiting life expectancy to less than 1 year - You are pregnant - You have had previous shoulder surgery on the affected side - You have rheumatoid arthritis in the affected shoulder - You are unwilling to be followed for the duration of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREEccentric Reaming

Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric ("high side") anterior reaming to within \< 10 degrees of neutral glenoid version.

PROCEDUREAugmented Glenoid Component Implantation

Patients will undergo standard glenoid preparation and implantation of a posteriorly augmented glenoid component. The degree of posterior augment will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.

PROCEDUREPosterior Glenoid Bone Grafting

Patient will undergo a total shoulder arthroplasty as per standard technique. Glenoid version will be restored to within 10 degrees of neutral with a posterior glenoid bone graft. The bone graft will be harvested from the humeral head and fixed to the posterior glenoid with mini-fragment screws.


Locations(1)

The Ottawa Hospital

Ottawa, Ontario, Canada

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NCT02966886


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